Asante Conset Infusion Set Recalled for Tubing Disconnects
Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that results in the administration of less insulin than intended, posing a significant risk of harm to patients.
Plain-English summary
Asante Solutions, Inc. is recalling Asante Conset Infusion Sets with 60cm tubing and 6mm cannula. The recall involves 1,392 kits distributed nationwide. The product is manufactured by Convatec in Lejre, Denmark, and distributed by Asante Solutions in Sunnyvale, California.
The recall was initiated due to reports of the infusion tubing disconnecting from the connector. This defect results in the leakage of insulin from the infusion set, which provides the patient with less insulin than intended.
Affected lots include 0230126, 5005801, and 5030167. The products are identified by Asante Catalog numbers FG-4226-5 and G-4147T, and Unomedical Item number 43-060-5266. Patients using these infusion sets should contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
- Manufacturer
- Asante Solutions, Inc.
- Affected units
- 1,392
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Asante Catalog number: FG-4226-5
- G-4147T
- Unomedical Item number:43-060-5266
- Lot numbers: 0230126 5005801 5030167.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Asante Solutions, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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